Dosing for ILARIS to Treat CAPS

ILARIS^® is not given as an intravenous infusion (infused inside a vein over time); it is given as a subcutaneous injection (right under the skin) by a doctor or nurse once every 8 weeks—just 6 or 7 treatments in a year.

At your doctor's request, Novartis can send a home health nurse to your home to give your child his or her ILARIS injection.

How Does ILARIS Work?

To understand how ILARIS works, it's important to start with the role of the immune system in Cryopyrin-Associated Periodic Syndromes (CAPS) and how inflammation (the body's way of protecting itself against sickness or injury) gets triggered in the body.

Inflammation with CAPS

ILARIS targets an important cause of CAPS symptoms

For children and adults with CAPS, the immune system (the body's natural defense system that protects against "foreign" invaders) produces too much of a substance called a cytokine
Too much of a cytokine called interleukin-1 beta (IL-1�) is an important cause of inflammation in CAPS. When IL-1� attaches to interleukin-1 receptors (IL-1R), the immune system triggers inflammation
For children and adults with CAPS, including FCAS or MWS, the immune system triggers inflammation even when there's no infection to fight. This can cause recurring CAPS symptoms, like rash and painful joints and/or muscles

Treatment with ILARIS

ILARIS targets IL-1� to help reduce inflammation

ILARIS is a biologic medicine, which means it's designed to target a specific source of inflammation. ILARIS targets IL-1�
By attaching to IL-1�, ILARIS helps to block its interaction with IL-1R
This action helps to stop the immune system from triggering inflammation

If your child is diagnosed with CAPS, including FCAS or MWS, ask a doctor whether ILARIS may be right for your child.

Next: Talking to a Doctor

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IMPORTANT SAFETY INFORMATION

ILARIS can cause serious side effects, including increased risk of serious infections. ILARIS can lower the ability of your immune system to fight infections. Your healthcare provider should:

test you for tuberculosis (TB) before you receive ILARIS.
monitor you closely for symptoms of TB during treatment with ILARIS.
check you for symptoms of any type of infection before, during, and after treatment with ILARIS.

Tell your healthcare provider right away if you have any symptoms of an infection such as fever, sweats or chills, cough, flu-like symptoms, weight loss, shortness of breath, blood in your phlegm, sores on your body, warm or painful areas on your body, diarrhea or stomach pain, or feeling very tired.

You should not receive ILARIS if you are allergic to canakinumab or any of the ingredients in ILARIS.

Before receiving ILARIS, tell your healthcare provider about all your medical conditions, including if you:

think you have or are being treated for an active infection.
have symptoms of infection.
have a history of infections that keep coming back.
have a history of low white blood cells.
have or have had HIV, Hepatitis B, or Hepatitis C.
are scheduled to receive any immunizations (vaccines). You should not get 'live vaccines' if you are receiving ILARIS.
are pregnant or planning to become pregnant. It is not known if ILARIS will harm your unborn baby. Tell your healthcare provider right away if you become pregnant while receiving ILARIS
received canakinumab while you were pregnant. It is important that you tell your baby's healthcare provider before any vaccinations are given to your baby within 4-12 months after you received your last dose of canakinumab before giving birth
are breastfeeding or planning to breastfeed. It is not known if ILARIS passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you receive ILARIS

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you take:

medicines that affect the immune system.
medicines called interleukin-1 (IL-1) blocking agents such as Kineret^® (anakinra) or Arcalyst^® (rilonacept).
medicines called Tumor Necrosis Factor (TNF) inhibitors such as Enbrel^® (etanercept), Humira^® (adalimumab), Remicade^® (infliximab), Simponi^® (golimumab), or Cimzia^® (certolizumab pegol).
medicines that affect enzyme metabolism.

Ask you healthcare provider for a list of these medicines if you are not sure.

ILARIS can cause serious side effects including:

serious infections.
decreased ability of the body to fight infections (immunosuppression). For people treated with medicines that cause immunosuppression like ILARIS, the chances of getting cancer may increase
allergic reactions. Allergic reactions can happen while receiving ILARIS. Call your healthcare provider right away if you have any of these symptoms of an allergic reaction: difficulty breathing or swallowing, nausea, dizziness or feeling faint, rash, itching or hives, palpitations (feels like your heart is racing), or low blood pressure
risk of infection with live vaccines. You should not get live vaccines if you are receiving ILARIS. Tell your healthcare provider if you are scheduled to receive any vaccines

The most common side effects of ILARIS when used for the treatment of CAPS include: cold symptoms, diarrhea, flu (influenza), runny nose, headache, cough, body aches, nausea, vomiting, and diarrhea (gastroenteritis), feeling like you are spinning (vertigo), weight gain, injection site reactions (such as redness, swelling, warmth, or itching), and nausea.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please see full Prescribing Information, including Medication Guide.

APPROVED USE

ILARIS^® (canakinumab) is a prescription medicine injected by your healthcare provider just below the skin (subcutaneous) used to treat adults and children aged 4 years and older who have auto-inflammatory diseases called Cryopyrin-Associated Periodic Syndromes (CAPS), including:

Familial Cold Autoinflammatory Syndrome (FCAS)
Muckle-Wells Syndrome (MWS)

It is not known if ILARIS is safe and effective when used to treat CAPS in children under 4 years of age.

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Dosing for ILARIS to Treat CAPS

How Does ILARIS Work?

ILARIS targets an important cause of CAPS symptoms

ILARIS targets IL-1� to help reduce inflammation

Leaving Novartis